pritumumab (CLNH 11) / Nascent Biotech - LARVOL DELTA

Characterization of pritumumab in murine models and primate safety study. (PubMed, Sci Rep) - "Overall, these data together suggest pritumumab is biologically active and animal models can be used to further understand the various functions of the antibody. Clinical trials in brain cancer patients assessing safety and efficacy of pritumumab as a therapeutic for brain cancer are in process."

Journal • Preclinical • Brain Cancer • CNS Tumor • Glioblastoma • Hematological Malignancies • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • VIM

Cell surface vimentin: a natural human immune response target for immunotherapy. (PubMed, Front Mol Med) - "One of these vimentin-reactive antibodies, pritumumab, has been used to treat brain cancer patients. This review summarizes data on mAbs reactive with cell surface vimentin and their origin from lymph nodes of cancer patients."

Journal • Review • Brain Cancer • Oncology • Solid Tumor • VIM

Safety Study of Pritumumab in Brain Cancer (clinicaltrials.gov) - P1 | N=15 | Completed | Sponsor: Nascent Biotech | Recruiting ➔ Completed | N=42 ➔ 15

Enrollment change • Trial completion • Brain Cancer • Glioblastoma • Glioma • Oligodendroglioma • Oncology • Solid Tumor

A phase 1 dose escalation of pritumumab in patients with refractory or recurrent gliomas or brain metastases. (PubMed, Neurooncol Adv) - P1 | "Pritumumab was well tolerated with no DLTs observed up to 16.2 mg/kg weekly. Further studies are warranted to determine clinical benefit in patients."

Clinical • Journal • P1 data • Brain Cancer • CNS Tumor • Constipation • Fatigue • Gastroenterology • Gastrointestinal Disorder • Glioblastoma • Glioma • Oncology • Solid Tumor

Nascent Prepares for Pivotal Phase II Research with Fresh Manufacturing Run (ACCESSWIRE) - "Nascent Biotech, Inc...announces that it is embarking on a fresh manufacturing run to ensure Pritumumab ('PTB') supplies are at maximum potency when patient dosing begins in the upcoming Phase II clinical trial....This announcement comes as the Company prepares for a Phase II trial that follows a very successful Phase I trial-where safety at five ascending dose cohorts was observed-involving 15 patients who received PTB for various types of brain tumors....Management anticipates that some research sites will open for the start of Phase II testing late this summer with actual patients involved later in 2024."

Commercial • New P2 trial • Brain Cancer • CNS Tumor • Glioblastoma • Oncology

Nascent Biotech and Manhattan BioSolutions Collaborate to Explore Pritumumab Antibody-Drug Conjugates (ACCESSWIRE) - "Nascent Biotech...announced today it has entered into a research collaboration agreement with Manhattan BioSolutions, Inc. (Manhattan Bio), an emerging biotech company focused on precision biologics, to explore antibody-drug conjugates (ADCs) using Nascent's lead clinical candidate pritumumab (PTB) as the tumor-targeting antibody element. Pritumumab (PTB) is a natural human antibody. This monoclonal antibody targets extracellular form of vimentin, a protein that has been linked to cancer growth and metastasis and is overexpressed in both brain and pancreatic cancers as well as other hard tumor cancers....Under the terms of the agreement, Manhattan Bio will perform PTB conjugations to industry standard linker-payloads and will evaluate the resulting ADCs in the in vitro cell assays."

Licensing / partnership • Pancreatic Cancer

Nascent Biotech Granted Japanese Patent for Crossing Blood-Brain Barrier (Issuer Direct) - "Nascent Biotech...is pleased to announce the Company has been issued a 'Method-of-Use' patent from the Japanese Patent Office ('JPO') for its primary asset, Pritumumab ('PTB'). Specifically, the patent approval is related to PTB's capacity to cross through the Blood-Brain Barrier ('BBB'). The patent allowance recognizes PTB's ability to act as a monotherapy, as well as its potential to act as a conjugate, bringing other therapies across the BBB."

Patent • Oncology

Nascent Biotech to Begin Phase II Clinical Trials for Brain Cancer (BioSpace) - "Nascent Biotech, Inc...announced today that the Company has been cleared by the FDA to begin Phase II clinical trials for brain cancer. This milestone allows the Company to continue advancing Pritumumab through the regulatory clinical processes in its use against Brain Tumors including Glioblastoma."

IND • New P2 trial • Brain Cancer • CNS Tumor • Glioblastoma • Oncology • Solid Tumor

Phase 1 study of pritumumab in brain cancer. (ASCO 2023) - P1 | "Single agent Pritumumab is safe up to a dose of 16.2 mg/kg every 7 days in brain tumor patients. A phase 2 study is being planned as single agent and in combination with checkpoint inhibitors in both recurrent gliomas and upfront with chemoradiation in newly diagnosed gliomas. Clinical trial information: NCT04396717."

P1 data • Anaplastic Astrocytoma • Anaplastic Oligoastrocytoma • Astrocytoma • Brain Cancer • Cervical Cancer • CNS Disorders • Constipation • Depression • Dermatology • Fatigue • Gastroenterology • Gastrointestinal Disorder • Glioblastoma • Glioma • Infectious Disease • Lung Cancer • Oligodendroglioma • Oncology • Pain • Pruritus • Psychiatry • Solid Tumor • VIM

Nascent Biotech Regains Worldwide Rights for Pritumumab (Barron's) - "Nascent Biotech, Inc...announced today that the Company and China based BioRay Pharmaceutical Co have mutually agreed to terminate the license agreement entered into on March 31, 2021. Nascent gains back worldwide marketiistribution ng and drights previously licensed to BioRay. Management concludes with gaining back the worldwide rights, the company is in a stronger position going forward."

Licensing / partnership • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Oncology • Solid Tumor

Nascent Biotech to Present Phase I Clinical Data at American Society of Clinical Oncology Annual Meeting (Issuer Direct) - "Nascent Biotech...announced today that the Company has been selected for a poster presentation at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting held in Chicago on June 2-6, 2023. The poster presentation, entitled 'Phase I Study of Pritumumab in Brain Cancer', will take place from 1:15-4:15 PM CDT on June 3rd, during the 'Central Nervous Systems Tumors' session in Hall A of McCormick Place Convention Center."

P1 data • Brain Cancer • CNS Tumor • Oncology • Solid Tumor

Nascent Submits Phase 2 Clinical Research Protocol to FDA for Review and Approval (Issuer Direct) - "Nascent Biotech...announced today that the Protocol for the Phase 2 clinical trials was submitted to the FDA for review and approval. The review is required for approval to commence the next phase in the development of Pritumumab ('PTB'). Data related to Phase 1 Clinical Research evaluating safety and tolerance for PTB as a treatment for Primary and Metastatic Brain Cancers has also been submitted to the FDA. The Company anticipates initial comments from the FDA approximately 30 days from the date of filing."

Clinical protocol • FDA event • Brain Cancer • CNS Tumor • Oncology • Solid Tumor

Nascent Announces the Completion of Its Phase1 Clinical Trials (Issuer Direct) - "Nascent Biotech...announced today that the Company has completed and closed its Phase I clinical trial evaluating safety and tolerance for Pritumumab ('PTB') as a treatment for Primary and Metastatic Brain Cancers. Previous announcements shared the end of the enrollment and dosing period of the Phase I trial. Nascent will continue to collect and evaluate the Clinical data from the Phase I trial as it prepares to submit results to the U.S. FDA for Phase II consideration."

Trial completion • Brain Cancer • CNS Tumor • Oncology • Solid Tumor

Nascent Completes Dosing Requirement in Final Cohort of Phase I Clinical Trial (Issuer Direct) - "Nascent Biotech... announced the completion of the dosing period of their Phase I Clinical Trial evaluating the safety and dose tolerance of Pritumumab ('PTB') as a treatment for Brain Cancer. The completion of dosing for the fifth and final Phase I cohort completes safety and dose escalation. The Company will now prepare to submit data and the Phase II Clinical Protocol to the United States Food and Drug Administration (the 'FDA') for evaluation."

Trial status • Brain Cancer • CNS Tumor • Oncology • Solid Tumor

Nascent Enrolls Final Patient Cohort in Phase I Brain Cancer Trial (Issuer Direct) - "Nascent Biotech...announced today the completion and closure of enrollment for the final cohort of patients involved in the Company's Phase I trial to evaluate Pritumumab ('PTB') as a treatment for Brain Cancer. Following the completion of patient dosing in this fifth and final cohort, the Company's Phase I trial will be complete. The Company will then prepare and submit research data to the FDA in preparation for the launch of its Phase 2 clinical research."

Enrollment closed • P1 data • Brain Cancer • CNS Tumor • Oncology • Solid Tumor

Nascent Biotech Receives Notice of the Issuance of US Patent No.11,494,394 (Issuer Direct) - "Nascent Biotech...announced today that the United States Patent and Trademark Office (the 'USPTO') will issue patent No. 11,492,394 on November 8, 2022 for claims related to the Company's lead candidate Pritumumab. The allowed patent, which is titled, 'KITS AND CONTAINERS FOR TREATING VIMENTIN EXPRESSING TUMORS' , provides broad protection for Pritumumab ('PTB') and the storage conditions related to its use in clinical applications....PTB is a natural human antibody that works by binding to Cell surface Vimentin (also referred to as ectodomain vimentin, or EDV), a protein expressed on the surface of epithelial cancers."

Patent • Oncology • Solid Tumor

Nascent Begins Enrollment of Final Patient Cohort to Complete Phase One Clinical Research (Issuer Direct) - "Nascent Biotech...announced today that the Company has enrolled the first patient of the fifth and final cohort of its Phase I clinical trial to evaluate Pritumumab ('PTB') as a treatment for Primary and Metastatic Brain Cancers....Following completion of dosing of the Fifth Cohort, the Company will prepare data for submission to the FDA in preparation for Phase II clinical research."

Trial status • Brain Cancer • CNS Tumor • Oncology • Solid Tumor

Nascent Biotech Completes Fourth Cohort in Phase 1 Human Trial for Primary and Metastatic Brain Cancer (Issuer Direct) - "Nascent Biotech...announced today the completion of the Fourth Cohort in dosing patients in the Company's Phase I trial to evaluate Pritumumab ('PTB') as a treatment for Brain Cancer, including Primary and metastatic Brain Tumors. After reviewing data gathered from the four completed cohorts, this milestone will allow the trial to advance to a fifth and final cohort....Following completion of dosing of the Fifth Cohort, the Phase I trial will be complete, and the Company will prepare data for submission to the FDA in preparation for Phase 2 clinical research."

Trial status • Brain Cancer • CNS Tumor • Oncology • Solid Tumor

Nascent Successfully Completes 2nd Cohort Dosing in Key Phase 1 Metastatic Brain Cancer Trial (Yahoo Finance) - "Nascent Biotech...is pleased to announce the completion of dosing of the second cohort of patients involved in the Company's Phase I trial to evaluate Pritumumab ('PTB') as a treatment for Brain Cancer, including Malignant Primary Brain Tumors and adult Brain Metastases."

Trial status • Anaplastic Astrocytoma • Anaplastic Oligoastrocytoma • Brain Cancer • CNS Tumor • Glioblastoma • Glioma • Medulloblastoma • Oncology • Solid Tumor

Nascent Biotech Commencing Enrollment of Second Cohort in Phase 1 Human Trial for Primary and Metastatic Brain Cancer (Issuer Direct) - “Nascent Biotech…announce the beginning of enrollment of the second cohort in dosing patients for its Phase I trial for Brain Cancer. This milestone allows the trial to triple the dosage levels over the first cohort to achieve the highest level without toxicity. Patient enrollment continues for Phase I.”

Enrollment status • Brain Cancer • CNS Tumor • Oncology • Solid Tumor

Nascent Biotech Announces Initial Dosing Underway in Phase 1 Human Trial for Primary and Metastatic Brain Cancer (BioSpace) - "Nascent Biotech, Inc...is pleased to announce that patients have been enrolled and initial dosing has begun in the Company's landmark Phase I trial to evaluate Pritumumab ('PTB') as a treatment option for Brain Cancer, including Malignant Primary Brain Tumors and adult Brain Metastases."

Trial status • Brain Cancer • Oncology

Safety Study of Pritumumab in Brain Cancer (clinicaltrials.gov) - P1; N=42; Recruiting; Sponsor: Nascent Biotech; Not yet recruiting ➔ Recruiting; Initiation date: Jun 2020 ➔ Mar 2021

Clinical • Enrollment open • Trial initiation date • Brain Cancer • Glioblastoma • Glioma • Oligodendroglioma • Oncology • Solid Tumor

Nascent Biotech Receives Full IND Clearance to Begin Phase I Human Trials for Brain Cancer (Yahoo Finance) - "On December 7, the Company received a letter from the US Food and Drug Administration (FDA) removing a partial clinical hold on Nascent's proprietary monoclonal antibody Pritumumab. This allows Nascent to commence Phase I Human Clinical Trials, effective immediately."

FDA event • Brain Cancer • Oncology

Unconventional immunotherapy with an unconventional target. (PubMed, Hum Antibodies) - "A clinical trial assessing higher doses of pritumumab as a therapeutic for brain cancer is expected to begin this year. Overall, these data together suggest pritumumab is suitable for further development as an anti-tumor therapeutic."

IO Biomarker • Journal • Review • Cervical Cancer • Oncology • Solid Tumor • VIM

Nascent Biotech to begin Phase 1 human trials for brain cancer drug (GlobeNewswire) - "Nascent Biotech, Inc…is pleased to announce that the Company will soon begin Phase 1 clinical trials for a treatment of Brain Cancer, including, glioblastoma (GBM), the deadliest form of brain cancer.The study will employ Nascent’s monoclonal, antibody, Pritumumab ('PTB') and will be conducted in collaboration with a Southern CA Cancer Center…"

New P1 trial • Brain Cancer • Glioblastoma • Oncology